DAIDS Protocol Checklist

For DAIDS-held IND studies, the responsibility to meet the reporting requirements falls within DAIDS. For other studies (e.g., network non-IND, non-DAIDS held IND, non-network non-IND, etc.), the responsibility generally lies with the grantee institution, organization, and/or IND holder.

This form is intended to be filled out electronically. This form will identify which conditions must be met to fulfill requirements set forth by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the NIH Policy on Dissemination of NIH-funded Clinical Trial Information. This form should be submitted along with to-be Version 1.0 main protocol documents at the time of Full Regulatory Review. In addition to the form, a memo from DAIDS describing recent updates to the form can be found below.

DAIDS Memorandum
January 2021

​DAIDS Protocol Checklist
Version 4.0 - September 2023 Initial Registration

For guidance and instruction of initial registrations to please see the following reference documents.

DAIDS CRSS Initial Registration Process
September 2022

How to Initiate the Initial Registration Process Memorandum
September 2022 Workflow Overview Flowcharts
August 2023

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